Duchenne Muscular Dystrophy Clinical Trial
Official title:
Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy
NCT number | NCT05274555 |
Other study ID # | 2019/07-65 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 27, 2019 |
Est. completion date | June 29, 2021 |
Verified date | June 2022 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Purpose: This study aimed to evaluate the construct validity and reliability of the Turkish version of the Upper Limb Short Questionnaire (ULSQ) in Duchenne muscular dystrophy (DMD). Materials and methods: A total of 41 children with DMD have participated in the study. Upper and lower extremities functional levels were assessed with Vignos Scale and Brooke Upper Extremity Functional Rating Scale, respectively. The construct validity of the questionnaire was determined using the correlation between the ULSQ and ABILHAND-Kids. The Cronbach alpha value was calculated to determine internal consistency. To determine test-retest reliability, 17 randomly selected children were evaluated seven days after the first evaluation, and the "Intraclass Correlation Coefficient (ICC)" value was calculated.
Status | Completed |
Enrollment | 41 |
Est. completion date | June 29, 2021 |
Est. primary completion date | April 25, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - being diagnosed with DMD, being between the ages of 5-18, not having any additional neurological disorder, volunteering to participate in the research Exclusion Criteria: - patients diagnosed after 10 years of age, patients who had never taken corticosteroids, and patients aged 14 years or older but were still ambulatory |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper Limb Short Questionnaire | The Upper Limb Short Questionnaire consists of questions about UE function (5 items), pain (6 items), and stiffness (3 items). ULSQ can be used as an identifier of arm-hand limitations during the clinical investigation. The total score changes between 0 and 14. Lower scores present children have more problems in the upper extremities. | 2 years | |
Primary | ABILHAND-Kids | That evaluates upper extremity function according to 18 different activities performed by children. The total score calculates by summing the grades that children get from each item and change between 0 and 36. Lower scores present lower ability while higher scores indicate higher ability of the hand/upper extremity in the ABILHAND-Kids. | 2 years | |
Primary | The Vignos Scale | This scale classifies patients' walking abilities in 10 grades ranging from 1 to 10. At the first level, the patient can walk and climb the steps without assistance, but at the last level, patient is confined to bed. | 2 years | |
Primary | The Brooke Upper Extremity Functional Rating Scale | It classifies upper extremity function with 6 different levels based on the children's upper extremity movements. Level 1 means patient can start the movement with the arms at the sides and fully joins the hands above the head, Level 6 is defined as unable to raise their hands to their mouths and cannot use their hands functionally. | 2 years |
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